Community-Based Participatory ResearchMBALNCT06482242
My Best Alaskan Life: A Community-Designed Intervention to Improve Youth/Young Adults' Sexual and Mental Health
A study testing My Best Alaska Life in people with Community-Based Participatory Research and Adolescent Behavior, run by University of Alaska Anchorage.
Trial summary
This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. Read more about this study
- Who is it for?
- Ages 14 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-Based Participatory Research, Adolescent Behavior, Mental Depression
- What is being tested?
- My Best Alaska Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Recruitment for the study will occur at 8 clinic/community sites (Figure 5), each enrolling 40 participants, inclu-sion criteria: (a) live in Alaska, (b) speak English, and (c) be between 14-26 years old, (d) have access to a smart phone or computer to self-administer surveys and access MBAL tool. Exclusion criteria include insufficient cognitive abilities to consent and previous use of the tool. During the initial phase (Weeks 0-4), participants are recruited across all 8 sites, and pre-intervention surveys are administered to all recruited participants. Recruit-ment will continue as needed at each site throughout the study, ensuring that new recruits complete the pre-intervention survey before receiving access to MBAL.
About this study
This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. By integrating motivational interviewing and the Health Belief Model, MBAL empowers individuals to make informed health decisions, thereby potentially reducing rates of sexually transmitted infections, HIV, and associated mental health issues. Long-term, this project aims to enhance overall health outcomes, particularly in underserved multicultural and Indigenous communities, while building local research capacity through undergraduate and graduate student engagement and mentorship.
Read the detailed description
SPECIFIC AIMS. Alaskan (AK) youth/young adults (Y/YA) face significant sexual and reproductive health disparities, leading the nation in sexually transmitted infections (STI), which increases risk of contracting HIV. (1-5) AK has the third and fourth highest rates of chlamydia and gonorrhea in the US, a 14% increase in syphilis cases compared to national rates between 2010-2020, and an estimated HIV prevalence of 142.3 per 100,000 (versus 80.7 nationally). (1, 2, 6-11) Concurrently, AK Y/YA experience disproportionately high levels of hopelessness and depression, increasing the likelihood of high-risk sexual behaviors. (12-15) Some 35.8% of AK Y/YA did not use a condom during their last sexual intercourse, and 16.9% do not use any pregnancy prevention method. (12-14) The Centers for Disease Control and American College of Obstetricians and Gynecologists recommend use of Reproductive Life Plan (RLP) tools, goal-setting guides for family planning. (16, 17) However, in previous pilot studies Y/YAs expressed need for an interactive tool to go beyond pregnancy intentions and address sexual and mental health disparities and diverse gender and sexuality identities.(18) Gaps: No RLP tools target sexual \& gender minority (SGM) Y/YA and the factors impacting their reproductive goals, including mental health, substance use, or relationship health. Recent systematic reviews of RLP tools note positive reception but lack evidence of efficacy in initiating knowledge or behavioral outcomes. (19) Proposed Project: To address these challenges, the team will employ "My Best Alaskan Life" (MBAL), an online decision-making tool crafted through a 4-year youth-centered, community-based participatory research effort (CBPR). Based on the Health Belief Model, MBAL integrates motivational interviewing to empower Y/YA to define priorities, identify supportive individuals, and enhance health literacy for discussions with healthcare providers and trusted adults. (20-28) This builds on two foundation and two implementation pilot studies where MBAL was refined by three youth advisory committees, five focus groups, and survey responses from 760 Y/YA (14-26) across AK.(18) Pilot outcomes endorsed MBAL's acceptability, appropriateness, feasibility, and capacity to enhance healthy sexual and mental beliefs, particularly for SGM participants. The proposed project builds on the CBPR approach, an established 4-year relationship with Y/YA and supportive adult partners across state and local health agencies, clinic and education health agencies across Alaska. This randomized controlled trial (RCT) will use a step-wedge design to assess MBAL's impact on Alaskan Y/YA through 8 clinical sites in rural and urban communities (n=40 participants per site, total n=320). This project will directly increase research capacity through annual cohorts of Y/YA co-investigators (5 undergraduate and 1 PhD student), recruited from the University of Alaska, who will be trained in qualitative research methods and mentored to lead the qualitative tool development, analysis, and dissemination.
Central hypothesis: MBAL has strong potential to effectively improve sexual \& mental health literacy and behavioral outcomes among Alaskan Y/YA through a self-guided, personalized assessment of health motivations, perceived threats, behavior evaluations, \& cultural factors that impact one's sexual choices, inclusive of SGM. (Measures with * are utilizing validated scales listed in Table 5 in C4.) AIM 1. Evaluate Short- and Long-Term Impact of MBAL Methods: Pre/Post Survey collected at enrollment/30 days/6 months (1A-1D). Analysis: Quantify changes in sexual health behaviors (measures: sexual health literacy*; condom/contraception use; HIV/STI testing; intention to delay sexual initiation.) Quantify changes in emotional/behavioral health (measures: mental health and well-being*; self-efficacy*; hopelessness*.) Quantify changes in commitment to factors impacting sexual health (measures: locus of control/perceived behavioral control*; motivation for change*; substance use*.) Conduct analyses to identify potential variations in effectiveness of MBAL for diverse groups. (measures: all.) AIM 2. Perform Process Evaluation Methods: Y/YA co-investigator coordinated interviews; semiannual, anonymous surveys with all stakeholders; feedback gathered at meetings; annual anonymous survey with Y/YA co-investigators. Analysis: Understand participant experience and perception of MBAL tool (measures: cultural competence; qualitative data (Y/YA co-investigator interviews). Understand experiences of research and community partners. (measures: Investment in Process and Product*; qualitative feedback. Understand experiences of Y/YA co-investigators. Measures: Student outcomes in research*.
AIM 3. Refine MBAL on Project Findings Methods: Feedback gathered at meetings; collaboration of research partners. 3A. Engage stakeholders in a collaborative process to make changes to MBAL based on RCT outcomes, to ensure it addresses multifaceted aspects of sexual and mental health. 3B. Y/YA co-investigators will integrate insights from MBAL and evaluation to finalize MBAL for dissemination as 1) a free state-wide tool, 2) for use by tribal and private health clinics, and 3) by school integrated health providers.
IMPACT: The MBAL tool, youth-developed dissemination and promotion campaign, and the evidence provided for RLP adaptations may serve as a framework for similar regions (ex. low provider access, multicultural and Indigenous youth, high sexual/mental health needs) to improve health outcomes. This proposal will also strengthen research opportunities by and for Alaskan Y/YA.
- Conditions
- Community-Based Participatory Research, Adolescent Behavior, Mental Depression, Sexual Health
- Being tested
- My Best Alaska Life
- Medical subject headings
- Adolescent Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Best Alaska LifeBehavioural
MBAL's combination of digital innovation, inclusive content, and youth-driven design positions it as a leading-edge intervention in the field of sexual health, with the potential to significantly impact the lives of Y/YA in AK and beyond. The open-access digital website enhances the reach and engagement of MBAL, particularly among adolescents who may prefer to seek information and support online in a private, self-paced setting. By allowing youth to fill out this tool at their own pace and return to their home page as they want to reflect/change answers, they can update it as their lives change. Additionally, MBAL incorporates interactive elements (question types of open response, ranking, scales, drag/drop; journaling prompts \& space) and personalized features (ex. avatars of common AK animals designed by Y/YA), allowing users to tailor their life planning experience according to their individual needs and preferences and return to their answers.
| Study group | Role | What they receive |
|---|---|---|
| Delayed access | Other | The step wedge design ensures that everyone has access to the intervention but data will be collected prior to the intervention being implemented at each site. Receives: Behavioral: My Best Alaska Life |
| Immediate access | Other | Sites will be randomized to receive intervention and those who receive intervention initially, will then be compared to those who do not at the same time period. Receives: Behavioral: My Best Alaska Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation for Change
This validated shortened tool includes 3 questions per topic area, with four topics areas: sexual and reproductive health, emotional and behavioral health, life planning, \& sub-stance use.
Measured: Baseline, immediate post, and 6 months post
Sexual Health
Condom/contraception use; HIV/STI testing; \& intention to delay sexual initiation (if not sexually active).
Measured: Baseline, immediate post, and 6 months post
Mental Health & Well-being
The Ryff Psychological Wellbeing Scale is an 18-item scale measuring six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Measured: Baseline, immediate post, and 6 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 May 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Based Participatory ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The research team will utilize a stepped wedge randomized clinical trial with 8 clinic/community sites, each recruiting 40 participants, for a total of 320 participants. Each site will transition from control (pre-intervention) to intervention (post-intervention) in a randomized, stepwise fashion. Sites are randomly assigned to different start times (in 4-week intervals) for the intervention, ensuring that every site eventually receives the intervention, while maintaining methodological rigor. From Weeks 0-4, baseline recruitment and pre-intervention survey administration will occur at all 8 sites. In Weeks 5-8 (Time Period 1), participants at Site 1 will start the intervention (each consented participant will be emailed a link to MBAL and the post-intervention survey upon completion.) In Weeks 9-12 (Time Period 2), participants at Site 2 will start the intervention, while Site 1 continues to recruit until 40 participants are enrolled in the study, and this pattern will continue.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alaska Anchorage
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Lessard, University of Alaska Anchorage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482242
- Sponsor's protocol ID
- UAlaskaAnchorage
- Acronym
- MBAL
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Best Alaskan Life: A Community-Designed Intervention to Improve Youth/Young Adults' Sexual and Mental Health
- ClinicalTrials.gov ID
- NCT06482242
- Acronym / sponsor ID
- MBAL / UAlaskaAnchorage
- Conditions
- Community-Based Participatory Research, Adolescent Behavior, Mental Depression, Sexual Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of Alaska AnchorageUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. By integrating motivational interviewing and the Health Belief Model, MBAL empowers individuals to make informed health decisions, thereby potentially reducing rates of sexually transmitted infections, HIV, and associated mental health issues. Long-term, this project aims to enhance overall health outcomes, particularly in underserved multicultural and Indigenous communities, while building local research capacity through undergraduate and graduate student engagement and mentorship.
Detailed description
SPECIFIC AIMS. Alaskan (AK) youth/young adults (Y/YA) face significant sexual and reproductive health disparities, leading the nation in sexually transmitted infections (STI), which increases risk of contracting HIV. (1-5) AK has the third and fourth highest rates of chlamydia and gonorrhea in the US, a 14% increase in syphilis cases compared to national rates between 2010-2020, and an estimated HIV prevalence of 142.3 per 100,000 (versus 80.7 nationally). (1, 2, 6-11) Concurrently, AK Y/YA experience disproportionately high levels of hopelessness and depression, increasing the likelihood of high-risk sexual behaviors. (12-15) Some 35.8% of AK Y/YA did not use a condom during their last sexual intercourse, and 16.9% do not use any pregnancy prevention method. (12-14) The Centers for Disease Control and American College of Obstetricians and Gynecologists recommend use of Reproductive Life Plan (RLP) tools, goal-setting guides for family planning. (16, 17) However, in previous pilot studies Y/YAs expressed need for an interactive tool to go beyond pregnancy intentions and address sexual and mental health disparities and diverse gender and sexuality identities.(18) Gaps: No RLP tools target sexual \& gender minority (SGM) Y/YA and the factors impacting their reproductive goals, including mental health, substance use, or relationship health. Recent systematic reviews of RLP tools note positive reception but lack evidence of efficacy in initiating knowledge or behavioral outcomes. (19) Proposed Project: To address these challenges, the team will employ "My Best Alaskan Life" (MBAL), an online decision-making tool crafted through a 4-year youth-centered, community-based participatory research effort (CBPR). Based on the Health Belief Model, MBAL integrates motivational interviewing to empower Y/YA to define priorities, identify supportive individuals, and enhance health literacy for discussions with healthcare providers and trusted adults. (20-28) This builds on two foundation and two implementation pilot studies where MBAL was refined by three youth advisory committees, five focus groups, and survey responses from 760 Y/YA (14-26) across AK.(18) Pilot outcomes endorsed MBAL's acceptability, appropriateness, feasibility, and capacity to enhance healthy sexual and mental beliefs, particularly for SGM participants. The proposed project builds on the CBPR approach, an established 4-year relationship with Y/YA and supportive adult partners across state and local health agencies, clinic and education health agencies across Alaska. This randomized controlled trial (RCT) will use a step-wedge design to assess MBAL's impact on Alaskan Y/YA through 8 clinical sites in rural and urban communities (n=40 participants per site, total n=320). This project will directly increase research capacity through annual cohorts of Y/YA co-investigators (5 undergraduate and 1 PhD student), recruited from the University of Alaska, who will be trained in qualitative research methods and mentored to lead the qualitative tool development, analysis, and dissemination.
Central hypothesis: MBAL has strong potential to effectively improve sexual \& mental health literacy and behavioral outcomes among Alaskan Y/YA through a self-guided, personalized assessment of health motivations, perceived threats, behavior evaluations, \& cultural factors that impact one's sexual choices, inclusive of SGM. (Measures with * are utilizing validated scales listed in Table 5 in C4.) AIM 1. Evaluate Short- and Long-Term Impact of MBAL Methods: Pre/Post Survey collected at enrollment/30 days/6 months (1A-1D). Analysis: Quantify changes in sexual health behaviors (measures: sexual health literacy*; condom/contraception use; HIV/STI testing; intention to delay sexual initiation.) Quantify changes in emotional/behavioral health (measures: mental health and well-being*; self-efficacy*; hopelessness*.) Quantify changes in commitment to factors impacting sexual health (measures: locus of control/perceived behavioral control*; motivation for change*; substance use*.) Conduct analyses to identify potential variations in effectiveness of MBAL for diverse groups. (measures: all.) AIM 2. Perform Process Evaluation Methods: Y/YA co-investigator coordinated interviews; semiannual, anonymous surveys with all stakeholders; feedback gathered at meetings; annual anonymous survey with Y/YA co-investigators. Analysis: Understand participant experience and perception of MBAL tool (measures: cultural competence; qualitative data (Y/YA co-investigator interviews). Understand experiences of research and community partners. (measures: Investment in Process and Product*; qualitative feedback. Understand experiences of Y/YA co-investigators. Measures: Student outcomes in research*.
AIM 3. Refine MBAL on Project Findings Methods: Feedback gathered at meetings; collaboration of research partners. 3A. Engage stakeholders in a collaborative process to make changes to MBAL based on RCT outcomes, to ensure it addresses multifaceted aspects of sexual and mental health. 3B. Y/YA co-investigators will integrate insights from MBAL and evaluation to finalize MBAL for dissemination as 1) a free state-wide tool, 2) for use by tribal and private health clinics, and 3) by school integrated health providers.
IMPACT: The MBAL tool, youth-developed dissemination and promotion campaign, and the evidence provided for RLP adaptations may serve as a framework for similar regions (ex. low provider access, multicultural and Indigenous youth, high sexual/mental health needs) to improve health outcomes. This proposal will also strengthen research opportunities by and for Alaskan Y/YA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research team will utilize a stepped wedge randomized clinical trial with 8 clinic/community sites, each recruiting 40 participants, for a total of 320 participants. Each site will transition from control (pre-intervention) to intervention (post-intervention) in a randomized, stepwise fashion. Sites are randomly assigned to different start times (in 4-week intervals) for the intervention, ensuring that every site eventually receives the intervention, while maintaining methodological rigor. From Weeks 0-4, baseline recruitment and pre-intervention survey administration will occur at all 8 sites. In Weeks 5-8 (Time Period 1), participants at Site 1 will start the intervention (each consented participant will be emailed a link to MBAL and the post-intervention survey upon completion.) In Weeks 9-12 (Time Period 2), participants at Site 2 will start the intervention, while Site 1 continues to recruit until 40 participants are enrolled in the study, and this pattern will continue.
| Arm | Type | Receives |
|---|---|---|
| Delayed access | Other | Behavioral: My Best Alaska LifeThe step wedge design ensures that everyone has access to the intervention but data will be collected prior to the intervention being implemented at each site. |
| Immediate access | Other | Behavioral: My Best Alaska LifeSites will be randomized to receive intervention and those who receive intervention initially, will then be compared to those who do not at the same time period. |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Best Alaska LifeMBAL's combination of digital innovation, inclusive content, and youth-driven design positions it as a leading-edge intervention in the field of sexual health, with the potential to significantly impact the lives of Y/YA in AK and beyond. The open-access digital website enhances the reach and engagement of MBAL, particularly among adolescents who may prefer to seek information and support online in a private, self-paced setting. By allowing youth to fill out this tool at their own pace and return to their home page as they want to reflect/change answers, they can update it as their lives change. Additionally, MBAL incorporates interactive elements (question types of open response, ranking, scales, drag/drop; journaling prompts \& space) and personalized features (ex. avatars of common AK animals designed by Y/YA), allowing users to tailor their life planning experience according to their individual needs and preferences and return to their answers. | Behavioural | Delayed access, Immediate access |
Primary outcome
Motivation for Change
Time frame: Baseline, immediate post, and 6 months post
This validated shortened tool includes 3 questions per topic area, with four topics areas: sexual and reproductive health, emotional and behavioral health, life planning, \& sub-stance use.
Sexual Health
Time frame: Baseline, immediate post, and 6 months post
Condom/contraception use; HIV/STI testing; \& intention to delay sexual initiation (if not sexually active).
Mental Health & Well-being
Time frame: Baseline, immediate post, and 6 months post
The Ryff Psychological Wellbeing Scale is an 18-item scale measuring six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing My Best Alaska Life in people with Community-Based Participatory Research and Adolescent Behavior, run by University of Alaska Anchorage.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation for Change (time frame: Baseline, immediate post, and 6 months post). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.